Objective To develop a new hemi-arthroplasty system-Trochanteric Prosthesis System (TC) for the treatment of unstable femoral intertrochanteric fractures in the elderly, so as to preserve bone mass and meet requirement of functional exercises at early stage. Methods A normal male adult volunteer was chosen to receive CT scanning at middle and upper regions of his both intact femur. The serial digitized image data of spiral CT in DICOM format were imported to finite element modeling software to establish a three-dimensional (3D) solid model of the proximal femur. The Pro/E software was used to conduct computer-aided design of the new hemi-arthroplasty prosthesis system and then its metal model was also made by rapid prototyping techniques. After repeated verification and improvement on cadaver femur, the femoral prosthesis was molded and assembled in the solid fracture mode for finite element analysis. The unstable femoral intertrochanteric fracture model obtained from the fresh cadaver of an elderly male was chosen to make A2.2 Type of such fracture model in AO classification system. The new hemi arthroplasty prosthesis system was implanted and assembled into the model and received mechanical testing, including material performance testing, prosthesis head/neck and stem fatigue testing, anti-compression and anti-torsion testing, according to the National Industrial Standard YY0117 and YY0118. Results The sample of new hemi-arthroplasty prosthesis sustained 5 million cycle (8 Hz) fatigue testing on the part of the head-neck and the stem body without any breakage and failure. With the sample implanted into the intertrochanteric fracture model, the maximum compressive strength and torsional strength of the sample reached over 2 kN and 15.5 N•m without failure, respectively. The contact stresses between the stem and the femur were mostly distributed at the region below the femoral trochanter, where the maximum average Von Mises stress values were 17.6~26.4 MPa. Stresses at the region of intertrochanteric fractures were at a low level. The maximum average Von Mises stress values at the greater and lesser trochanter region were 2.7 and 4.9 MPa, respectively. Conclusions The new developed hemi-arthroplasty prosthesis has the advantages of easy performance, reliable fixation, sufficient bone preservation and it is capable of fulfilling the demands of early weight bearing and functional exercises. It is suitable for the treatment of unstable femoral intertrochanteric fractures in the elderly.

Antibodies, Monoclonal, Murine-Derived ; therapeutic use ; Antineoplastic Agents ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Benzamides ; Cyclophosphamide ; therapeutic use ; Doxorubicin ; therapeutic use ; Drug Delivery Systems ; methods ; Gastrointestinal Stromal Tumors ; drug therapy ; Humans ; Imatinib Mesylate ; Indoles ; therapeutic use ; Leukemia, Lymphocytic, Chronic, B-Cell ; drug therapy ; Leukemia, Myeloid ; drug therapy ; Lymphoma, Large B-Cell, Diffuse ; drug therapy ; Mutation ; Neoplasms ; drug therapy ; genetics ; metabolism ; Piperazines ; therapeutic use ; Prednisone ; therapeutic use ; Pyrimidines ; therapeutic use ; Pyrroles ; therapeutic use ; Receptor, Epidermal Growth Factor ; genetics ; metabolism ; Remission Induction ; Rituximab ; Vincristine ; therapeutic use

OBJECTIVETo study the expression regularity of vascular endothelial growth factor (VEGF) during the process of fracture healing, and the type of VEGF receptor expressed in the vascular endothelial cells of the fracture site.

METHODSThe fracture model was made in the middle part of left radius in 35 rabbits. The specimens from the fracture site were harvested at 8, 24, 72 hours and 1, 3, 5, 8 weeks, and then fixed, decalcified, and sectioned frozenly to detect the expression of VEGF and its receptor at the fracture site by in situ hybridization and immunochemical assays.

RESULTSVEGF mRNA and VEGF expression was detected in many kinds of cells at the fracture site during 8 hours to 8 weeks after fracture. Flt1 receptor of VEGF was found in the vascular endothelial cells at the fracture site during 8 hours to 8 weeks after fracture, and strong expression of flk1 receptor was detected from 3 days to 3 weeks after fracture.

CONCLUSIONSThe expression of VEGF and flt1 receptor appears during the whole course of fracture healing, especially from 1 to 3 weeks. Flk1 receptor is highly expressed in a definite period after fracture. VEGF is proved to be involved in the vascular reconstruction and fracture healing.

Animals ; Endothelial Cells ; chemistry ; Female ; Fracture Healing ; physiology ; Immunohistochemistry ; In Situ Hybridization ; Male ; Rabbits ; Receptors, Vascular Endothelial Growth Factor ; analysis ; Vascular Endothelial Growth Factor A ; analysis

OBJECTIVETo evaluate the efficacy and safety of subcutaneous injection of recombinant human interleukin-2 (Proleukin) in the treatment of metastatic renal cell carcinoma (RCC).

METHODSForty-one patients with pathologically confirmed metastatic RCC after radical nephrectomy were enrolled into this study. Two or four consecutive cycles of subcutaneous injection of rhLL-2 were given, with each cycle duration of five weeks consisting of 4 weeks of treatment and one week of rest. The rhLL-2 was injected twice daily subcutaneously at a dose of 9 MIU on D1-D5 during week one, then 9 MIU twice daily on D1-D2 and followed by 9 MIU daily on D3-D5 during week 2-4. Patients were evaluated after the second cycle of treatment. If an objective response or stable disease was observed, the patient would receive another two cycles of treeatment.

RESULTSOf the 41 patients, the overall objective response rate was 17.1% (95% confidence interval, 5.6% to 28.6%) with a complete response (CR) rate of 0.0% and partial response rate (PR) of 17.1%. However, nineteen patients (46.3%) still had a stable disease (SD), and 15 (36.6%) had progressed disease (PD). The disease control rate was 63.4% and the median time to progression (mTTP) was 6 months. The 1-year survival rate was 71.2% with a median overall survival (mOS) rate of 22.5 months. Among 36 PP population, the overall objective response rate was 19.4% (95% confidence interval, 6.5% to 32.3%) with CR rate of 0.0% and PR rate of 19.4%. Sixteen patients(44.4%) had stable disease, and 13 (36.1%) progressed disease. The disease control rate was 63.9%. The 1-year survival rate was 66.7% with a median time to progression of 6 months. The median overall survival (mOS) had not reached yet. The follow-up data showed that the long term survival of the patient who responsed to the IL-2 therapy can be prolonged. Severe toxicity (> or = grade III) was rarely observed. Grade I or II toxicities such as fatigue (100.0%) and fever (82.9%) were frequently observed but reversible.

CONCLUSIONSubcutaneous injection of recombinant human interleukin-2 may prolong the survival of patients with a metastatic renal cell carcinoma. This regimen is tolerable with rare severe toxicities.

Adult ; Aged ; Antineoplastic Agents ; administration & dosage ; adverse effects ; therapeutic use ; Carcinoma, Renal Cell ; drug therapy ; secondary ; surgery ; Disease Progression ; Fatigue ; chemically induced ; Female ; Fever ; chemically induced ; Follow-Up Studies ; Humans ; Injections, Subcutaneous ; Interleukin-2 ; administration & dosage ; adverse effects ; analogs & derivatives ; therapeutic use ; Kidney Neoplasms ; drug therapy ; pathology ; surgery ; Lung Neoplasms ; secondary ; Male ; Middle Aged ; Nephrectomy ; Proportional Hazards Models ; Recombinant Proteins ; administration & dosage ; adverse effects ; therapeutic use ; Remission Induction ; Survival Rate

OBJECTIVETo investigate the antitumor efficacy, time to tumor progression (TTP) and toxicity of gefitinib (Iressa, ZD1839)--a selective epidermal growth factor receptor tyrosine kinase inhibitor in the treatment of male patients with advanced non-small-cell lung cancer (NSCLC). Methods Fifty-nine male patients with stage IV NSCLC orally took Iressa 250 mg once daily until disease progression or intolerable toxicity ocurred. They were required to conduct tumor-evaluation before the treatment, one month after Iressa administration and then every other month.

RESULTSOf these 59 patients, no complete regression was observed, 23.7% had partial response (PR), and 16.9% stable disease (SD) with a disease control (PR + SD) rate of 40.7%, while 59.3% had progress of disease (PD). The median time to tumor progression (TTP) was 1.8 months, and the median survival was 8.5 months. Fifty-nine patients were followed up over one year, 35 over two year and 15 over three year, and the 1-, 2- and 3-year survival rates were 42.4%, 17.1% and 13.3%. The most common adverse effects were grade 1 or 2 skin reaction and diarrhea.

CONCLUSIONIressa is effective in antitumor for the male patients with advanced non-small-cell lung cancer, and can improve the survival for those responsing to gefitinib. The adverse effects are usually tolerable.

Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; pathology ; Diarrhea ; chemically induced ; Disease Progression ; Exanthema ; chemically induced ; Follow-Up Studies ; Humans ; Lung Neoplasms ; drug therapy ; pathology ; Male ; Middle Aged ; Neoplasm Staging ; Quinazolines ; adverse effects ; therapeutic use ; Receptor, Epidermal Growth Factor ; antagonists & inhibitors ; therapeutic use ; Remission Induction ; Survival Rate

OBJECTIVETo evaluate the efficacy, side-effects and quality of life in the advanced colorectal cancer patients treated by irinotecan plus fuorouracil and leucovorin with thalidomide or without thalidomide.

METHODSEligible patients were randomly assigned to the treatment group and control group in a 1:1 ratio. In the treatment group, 32 evaluable patients were treated with irinotecan 180 mg/m2 i. v. on day 2, fuorouracil 400 mg/m2 bolus on day 1, 2 at a dose of 1200 mg/m2 civ. for 43 hours; leucovorin 200 mg/m2 i. v. on day 1, 2; thalidomide 300 mg, orally on day 1 - 14, two weeks as a cycle. In the control group, the regimen was the same as in the treatment group except oral intake of thalidomide.

RESULTSThe response rate was 28.1% in the treatment group vs. 15.2% in the control group (P = 0.2034) with a median TTP of 3.8 months vs. 2. 5 months (P = 0.1312). Furthermore, there was no statistically difference either between two groups regarding to adverse effects.

CONCLUSIONIrinotecan plus fuorouracil and leucovorin without oral intake of thalidomide is as effective and tolerable as irinotecan plus fuorouracil and leucovorin combined with oral thalidomide for advanced colorectal cancer.

Adenocarcinoma ; drug therapy ; Adolescent ; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Camptothecin ; administration & dosage ; analogs & derivatives ; Colorectal Neoplasms ; drug therapy ; Diarrhea ; chemically induced ; Disease Progression ; Female ; Fluorouracil ; administration & dosage ; Humans ; Leucovorin ; administration & dosage ; Male ; Middle Aged ; Remission Induction ; Survival Analysis ; Thalidomide ; administration & dosage ; Treatment Outcome

OBJECTIVEThe purpose of this phase I/II study is to investigate the safety/toxicity profile of weekly administration of docetaxel in combination with cisplatin for the chemo-naive patients with advanced non-small cell lung cancer (NSCLC), and to evaluate the efficacy of this regime.

METHODSIn phase I trial, 15 patients were included. IV infusion of escalating doses of docetaxel consisting of four levels from 25 to 40 mg/m2 (25, 30, 35, 40 mg/m2) on D1, 8, 15 and cisplatin of 75 mg/m2 on D1 was administered. The regime was repeated every 4 weeks. Blood samples were obtained on D1, 15 in the first cycle to measure the PK. Dose limiting toxicity (DLT) was determined in cycle 1 and defined as any grade 3 non-hematologic toxicity which could not be reverted into grade less than grade 2 within 4 days or any grade 4 hematologic toxicity. Eighty-three patients completed their phase II study with administration of docetaxel at a dose of 35 mg/m2 based on the data of phase I trial.

RESULTSIn the phase I trial, grade 3/4 neutropenia was mainly observed in patients who received docetaxel of 40 mg/m2 (level 4) with one patient suffering from an infection signifying dose limiting toxicity (DLT). Non-hematological toxicities including nausea/vomiting, alopecia, fluid retension and asthenia were tolerable. Based on these data, the maximum tolerence dose (MTD) did not reach the level of weekly giving docetaxel at a dose of 40 mg/m2 in combination with cisplatin 75 mg/m2 every 4 weeks. The pharmacokinetic/dynamics results There was no statistically significant difference between clearance value among the 4 dose levels of docetaxel from 25 to 40 mg/m2 when measured by Cmax and AUC. The pharmacokinetics of docetaxel was not influenced by the presence of co-administration of cisplatin when compared D1 with D15 as based on CmaxN, AUCN and CL. In the phase II trial, totally 83 patients received 216 cycles of chemotherapy. One CR (complete response) and 22 PR (partial response) were achieved with an objective response rate of 27.7% in this series and 30.7% in the evaluable patients. The 1-year survival was 48.6% with a median survival of 10.7 months (range: 3-34 months). Hematologic toxicities were the major side effects, though most were mild; grade III/IV neutropenia developed in 15%. The common non-hematologic toxicities were nausea, vomiting and asthenia.

CONCLUSIONWeekly consecutive administration of docetaxel on D1, 8, 15 for 3 weeks plus cisplatin on D1 is tolerable and effective with minimal myelosuppression in chemo-naive patients with advanced NSCLC.

Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Area Under Curve ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; pathology ; Cisplatin ; administration & dosage ; adverse effects ; Drug Administration Schedule ; Female ; Humans ; Lung Neoplasms ; drug therapy ; pathology ; Male ; Middle Aged ; Neoplasm Staging ; Neutropenia ; chemically induced ; Remission Induction ; Survival Rate ; Taxoids ; administration & dosage ; adverse effects ; Vomiting ; chemically induced

OBJECTIVETo evaluate the efficacy and adverse events of irinotecan (CPT-11) combined with cisplatin (DDP) in the treatment of patients with advanced non-small cell lung cancer (NSCLC).

METHODSOf 36 NSCLC patients consisting of 23 males and 13 females with a medium age of 52 years included, there were 26 adenocarcinomas, 7 squamous cell carcinomas, 1 adeno-squamous cell carcinoma and 2 unclassified types; 13 stage III B and 23 stage IV; 24 chemonaive and 12 previously treated by chemotherapy with a medium Karnofsky status of 90. All patients had measurable or evaluable parameters. The regimen was administered as following: CPT-11 60 mg/m2, IV, D1, 8 and 15; DDP 80 mg/m2, IV, D1; every 28 days as a cycle.

RESULTSTotally, 97 cycles were carried out in these 36 patients with a medium cycles of 3. Of 35 evaluable patients, 22.9% (8/35) achieved partial response, 60.0% (21/35) had stable disease and 17.1% (6/35) progressive disease. The response rate was 29.2% (7/24) for chemonaive patients and 9.1% (1/11) for these previously treated. The 1-year survival rate was 45.4% with a medium time to tumor progression (TTP) of 199 days for the responders. The incidence rate of grade III/IV adverse events were: 16.7% for neutropenia, 13.9% alopecia, 5.6% diarrhea, 2.8% nausea and vomiting, respectively.

CONCLUSIONIrinotecan plus cisplatin is effective with tolerable adverse events in treating patients with advanced non-small cell lung cancer, but further investigation trials are needed.

Adult ; Aged ; Alopecia ; chemically induced ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Camptothecin ; administration & dosage ; adverse effects ; analogs & derivatives ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; mortality ; pathology ; Cisplatin ; administration & dosage ; adverse effects ; Diarrhea ; chemically induced ; Female ; Humans ; Lung Neoplasms ; drug therapy ; mortality ; pathology ; Male ; Middle Aged ; Neoplasm Staging ; Neutropenia ; chemically induced ; Remission Induction ; Survival Rate

OBJECTIVETo study the proportion and mechanism of relieving asthma of drug partnership comprising herbal Ephedrae & Pheretima.

METHODTo study relaxant effect on 10 micromol x L(-1) carbachol (CCh) and 10 micromol x L(-1) histamine (His) precontracted isolated tracheal rings and lowering effect on short-circuit current (Isc) increase induced by 10 micromol x L(-1) CCh with 3 proportions of 1:1, 1:3, 1:9 extract.

RESULT1:3 proportions dose-dependently relaxed CCh-precontracted isolated tracheal rings, IC50 of 1:1, 1:3 is 7.5, 15 mg x mL(-1) respectively, 1:9 could not produce 50% inhibition effect on CCh-evoked contraction; 3 proportions also dose-dependently relaxed His-precontracted isolated tracheal rings, IC50 of 1:9, 1:3 and 1:1 is 0.19, 0.61, 1.8 mg x mL(-1) respectively. On the other hand,the orders potency of the decrease effect on CCh-evoked short circuit current increase is 1:3 > 1:1 > 1:9. The difference is not significant (P < 0.05).

CONCLUSIONHerbal Ephedrae & Pheretima had tracheal muscle relaxant and epithelium ion secretion inhibition effect, its mechanism of relieving asthma involved anti-CCh and anti-His effect 1:3 was the most appropriate dosage ratio in the anti-asthmatic drug partnership.

Animals ; Anti-Asthmatic Agents ; administration & dosage ; pharmacology ; Asthma ; physiopathology ; Dose-Response Relationship, Drug ; Drugs, Chinese Herbal ; administration & dosage ; isolation & purification ; pharmacology ; Ephedra sinica ; chemistry ; Guinea Pigs ; Histamine Antagonists ; pharmacology ; In Vitro Techniques ; Male ; Materia Medica ; administration & dosage ; isolation & purification ; pharmacology ; Muscle Relaxation ; drug effects ; Muscle, Smooth ; drug effects ; Oligochaeta ; chemistry ; Plants, Medicinal ; chemistry ; Rats ; Rats, Sprague-Dawley

OBJECTIVETo evaluate the difference of efficacy, side-effects and quality of life in advanced non-small-cell lung cancer (NSCLC) patients treated with oxaliplatin plus vinorelbine or cisplatin plus vinorelbine.

METHODSEligible patients were randomly assigned to NL (oxaliplatin + vinorelbine) group and NP (cisplatin + vinorelbine) group in a 2:1 ratio. In the NL group, 70 evaluable cases were treated with oxaliplatin 130 mg/m(2) i.v. on day 2, and vinorelbine 25 mg/m(2) i.v. on days 1 and 8 in 21 days per cycle. In the NP group, 32 evaluable cases were treated with cisplatin 80 mg/m(2) i.v. divided to 2 - 3 days dosing, 21 days per cycle, and vinorelbine administered by the same way as in the NL group. The response rate, time to progression (TTP), one-year survival, side-effects and the quality of life were observed.

RESULTSThe response rate was 35.7% vs. 43.8% (P = 0.4), median TTP was 4.7 months vs. 5.5 months (P = 0.6), one-year survival rate was 38.5% vs. 58.6% (P = 0.07) in the NL and NP groups, respectively. Grade I-II neuro-sensory toxicity occurred significantly more frequent in NL group than in NP group (68.4% vs. 36.4%, P = 0.0017). However, Grade I-II granulocytopenia was significantly less occurred in NL group than in NP group (49.4% vs. 70.6%, P = 0.037). There was no statistically difference between the two groups regarding quality of life.

CONCLUSIONDue to good efficacy and tolerability, the NL regimen offered a new candidate for treating advanced NSCLC.

Adolescent ; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; Cisplatin ; administration & dosage ; Drug Administration Schedule ; Female ; Humans ; Lung Neoplasms ; drug therapy ; Male ; Middle Aged ; Organoplatinum Compounds ; administration & dosage ; Quality of Life ; Treatment Outcome ; Vinblastine ; administration & dosage ; analogs & derivatives